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Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain

27. maj 2026 opdateret af: Octane Innovation Inc.

A Randomized, Double-blind, Sham-controlled Study to Evaluate the Efficacy and Safety of the Octane [Aether] Bioelectricity Device for the Management of Chronic Low Back Pain

The goal of this clinical trial is to evaluate the safety of the Octane Aether device and to determine whether the device is effective in treating symptoms of non-specific chronic low back pain in adults. The Octane Aether is a wearable device that produces specific magnetic field outputs and is designed for daily use in a home setting. The main objectives of the trial are:

  • To measure the change in patient-reported pain scores during active treatment with the device compared to a sham treatment, and
  • To define and describe the adverse effects, if any, of the Octane Aether device when administered according to the protocol.

Every participant will evaluate three active output modes and a sham output using the same device. Patient-reported outcomes will inform the effectiveness of each output mode and help identify the need for personalization in magnetic field therapy.

Participants will:

  • Use the device at home for 60 minutes every day for 10 weeks,
  • Report daily pain scores using an electronic visual analog scale for pain intensity,
  • Visit the clinic 5 times over the course of the 13 week trial for checkups and device changes,
  • Respond to 3 phone calls for checkups, and
  • Fill various questionnaires related to disability, quality of life, and their back pain.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7K 0J7
        • Kingston Orthopaedic Pain Institute
        • Kontakt:
        • Ledende efterforsker:
          • Thomas Gregory

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Able to provide informed consent;
  • Aged 18-65;
  • Pain intensity of at least 5 on a numerical rating scale (0-10);
  • Experiencing chronic low back pain that has persisted for ≥3 months;
  • Pain localized primarily to the lumbar spine region;
  • Conservative treatments, such as physical therapy, NSAIDs and lifestyle changes, have failed over the past 6 months. Participants are allowed to continue conservative treatments, but changes to use/frequency will be tracked; and
  • Must be able to attend 5 in-person clinic appointments over the 13-week study period.

Exclusion Criteria:

  • Began using new prescription medication for pain within the past 3 months;
  • Lumbar spine surgery (within the past 12 months);
  • Body Mass Index (BMI)> 35. The device may have diminished effectiveness and/or may not fit individuals with high BMI;
  • Presence of a cardiac pacemaker;
  • Pregnancy or breastfeeding;
  • Presence of ferromagnetic implants or body piercings (e.g., navel piercings) in the lumbar region, including hip implants/replacements or similar in the pelvic region, that could interfere with device function;
  • Inability to put on, adjust, and/or operate the wearable device without assistance;
  • Prior use of PEMF, or other electromagnetic field-emitting device, for the treatment of pain symptoms;
  • No, or inconsistent, access to internet (emailed surveys are used for daily data collection); and
  • Any condition or diagnosis that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence Group 1
Participants receive active/sham treatments in the following sequence: EMF A, EMF B, Sham, EMF C
Enhed: Pulsed electromagnetic field stimulator

The Octane Aether is a body-worn device that generates pulsed magnetic fields of specific characteristics designed to target cellular behaviour in relation to chronic pain signalling. The device features four different output modes (3 active and 1 sham) to enable an investigation of the need for personalized pain management. The specific characteristics of the output modes are blinded from the participants and study team and are labelled here as EMF A, EMF B, EMF C, and Sham. The device firmware is programmed to automatically change the output mode every two weeks. The device produces no sound or thermal effects.

When operating in the sham mode, the device appears identical to active output, but no current is applied to the body-worn coil applicator and no magnetic field is generated.

Andre navne:
  • Octane Aether
  • Octane Bioelectricity Device
  • PEMF device
  • EMF therapy
Eksperimentel: Sequence Group 2
Participants receive active/sham treatments in the following sequence: EMF B, EMF C, EMF A, Sham
Enhed: Pulsed electromagnetic field stimulator

The Octane Aether is a body-worn device that generates pulsed magnetic fields of specific characteristics designed to target cellular behaviour in relation to chronic pain signalling. The device features four different output modes (3 active and 1 sham) to enable an investigation of the need for personalized pain management. The specific characteristics of the output modes are blinded from the participants and study team and are labelled here as EMF A, EMF B, EMF C, and Sham. The device firmware is programmed to automatically change the output mode every two weeks. The device produces no sound or thermal effects.

When operating in the sham mode, the device appears identical to active output, but no current is applied to the body-worn coil applicator and no magnetic field is generated.

Andre navne:
  • Octane Aether
  • Octane Bioelectricity Device
  • PEMF device
  • EMF therapy
Eksperimentel: Sequence Group 3
Participants receive active/sham treatments in the following sequence: EMF C, Sham, EMF B, EMF A
Enhed: Pulsed electromagnetic field stimulator

The Octane Aether is a body-worn device that generates pulsed magnetic fields of specific characteristics designed to target cellular behaviour in relation to chronic pain signalling. The device features four different output modes (3 active and 1 sham) to enable an investigation of the need for personalized pain management. The specific characteristics of the output modes are blinded from the participants and study team and are labelled here as EMF A, EMF B, EMF C, and Sham. The device firmware is programmed to automatically change the output mode every two weeks. The device produces no sound or thermal effects.

When operating in the sham mode, the device appears identical to active output, but no current is applied to the body-worn coil applicator and no magnetic field is generated.

Andre navne:
  • Octane Aether
  • Octane Bioelectricity Device
  • PEMF device
  • EMF therapy
Eksperimentel: Sequence Group 4
Participants receive active/sham treatments in the following sequence: Sham, EMF A, EMF C, EMF B
Enhed: Pulsed electromagnetic field stimulator

The Octane Aether is a body-worn device that generates pulsed magnetic fields of specific characteristics designed to target cellular behaviour in relation to chronic pain signalling. The device features four different output modes (3 active and 1 sham) to enable an investigation of the need for personalized pain management. The specific characteristics of the output modes are blinded from the participants and study team and are labelled here as EMF A, EMF B, EMF C, and Sham. The device firmware is programmed to automatically change the output mode every two weeks. The device produces no sound or thermal effects.

When operating in the sham mode, the device appears identical to active output, but no current is applied to the body-worn coil applicator and no magnetic field is generated.

Andre navne:
  • Octane Aether
  • Octane Bioelectricity Device
  • PEMF device
  • EMF therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in patient-reported pain scores during active treatment compared to the sham treatment period
Tidsramme: From start of Treatment Period 1 (Week 2) to end of Treatment Period 4 (Week 9)
The difference in the mean pain VAS of scores reported in the second week of each active treatment period and the mean VAS of the second week of the same participant's sham period.
From start of Treatment Period 1 (Week 2) to end of Treatment Period 4 (Week 9)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse effects associated with the use of the Octane Aether
Tidsramme: From start of device use (Week 2) to follow-up appointment (Week 13 - end of study)
To define and describe the adverse effects of the Octane Aether when administered according to the clinical trial protocol. Participants and the study team will report adverse events associated with use of the device or device malfunctions.
From start of device use (Week 2) to follow-up appointment (Week 13 - end of study)
Effect of treatment on quality of life and disability index
Tidsramme: From end of first treatment period (Week 3) to end of fourth treatment period (Week 9)
The Octane Aether's effect is evaluated using the Roland-Morris Disability questionnaire, which assesses low back pain's influence on disability and quality of life. The questionnaire is completed after each active and sham treatment period and compared.
From end of first treatment period (Week 3) to end of fourth treatment period (Week 9)
Net change in perceived pain intensity (start to end)
Tidsramme: From baseline week (pre-intervention) to end of Treatment Period 4 (Week 9)
The change in mean pain VAS scores from the baseline week to the final week of Treatment Period 4 (Week 9).
From baseline week (pre-intervention) to end of Treatment Period 4 (Week 9)
Net effect of intervention on disability index
Tidsramme: From baseline (Week 1) to end of Treatment Period 4 (Week 9)
Change in Roland-Morris Disability questionnaire responses from Baseline to end of Treatment Period 4.
From baseline (Week 1) to end of Treatment Period 4 (Week 9)
Effect of Octane Aether EMF treatment on general health (physical and emotional)
Tidsramme: From Week 1 to Week 9
Participants respond to the RAND 36-item health survey after Week 1 and Week 9 and the change in category scores associated with physical and emotional health and quality of life are analyzed.
From Week 1 to Week 9
Longevity of the effect of Octane Aether treatment
Tidsramme: From end of device use (Week 11) to follow-up appointment (Week 13)
VAS for pain reports are used to assess changes in pain intensity two weeks after the end of intervention use to evaluate whether there is a lasting effect from the treatment.
From end of device use (Week 11) to follow-up appointment (Week 13)
Longevity of the intervention effect on disability and quality of life
Tidsramme: From end of device use (Week 11) to follow-up appointment (Week 13)
Roland-Morris Disability Questionnaire responses are used to evaluate the potential lasting effect of the interventional device after stopping daily use.
From end of device use (Week 11) to follow-up appointment (Week 13)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effectiveness of EMF A vs B vs C
Tidsramme: From Treatment Period 1 (Week 2) to 4 (Week 9)
Compare the change in pain VAS scores reported from start to finish of each active and sham output mode.
From Treatment Period 1 (Week 2) to 4 (Week 9)
Output mode preference
Tidsramme: Treatment Period 5 (Week 10)
Tally of output mode that each participant chose to repeat during Treatment Period 5. Participants are asked to select their preferred mode.
Treatment Period 5 (Week 10)
Changes in medication use
Tidsramme: Responses recorded at Baseline and all scheduled appointments (after Week 1, 3, 5, 7, 9, 11, and 13)
To assess whether the use of the interventional device affects how participants report using (non-prescription) medication (dosage and frequency).
Responses recorded at Baseline and all scheduled appointments (after Week 1, 3, 5, 7, 9, 11, and 13)
Device performance - Temperature
Tidsramme: Measurement data exported from the device after the device is returned during the Week 11 appointment.
Device performance is assessed by analyzing coil temperature sensor measurements recorded whenever the device is in use. Temperature data is compared to calibration measurements.
Measurement data exported from the device after the device is returned during the Week 11 appointment.
Device performance - Magnetic Flux Density
Tidsramme: Measurement data exported from the device after the device is returned during the Week 11 appointment.
Device performance is assessed by analyzing magnetic flux density measurements collected using a Hall-effect sensor embedded in the coil applicator. Magnetic flux density data recorded during each treatment session is compared to calibration measurements as a measure of performance and consistency.
Measurement data exported from the device after the device is returned during the Week 11 appointment.
Device performance - Current
Tidsramme: Measurement data exported from the device after the device is returned during the Week 11 appointment.
Device performance is assessed by analyzing data received from a current sensor that measures the current through the coil applicator. Current measurements, recorded during each treatment session, are compared to calibration data at the end of the study.
Measurement data exported from the device after the device is returned during the Week 11 appointment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Octane Innovation Inc.

Samarbejdspartnere

Kingston Health Sciences Centre
Limestone Clinical Trial Unit
Providence Care, Kingston, ON, Canada

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Bioelectricity_FP01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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